EP3509671B1 - Mécanisme de réglage de dose - Google Patents

Mécanisme de réglage de dose Download PDF

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Publication number
EP3509671B1
EP3509671B1 EP17764597.5A EP17764597A EP3509671B1 EP 3509671 B1 EP3509671 B1 EP 3509671B1 EP 17764597 A EP17764597 A EP 17764597A EP 3509671 B1 EP3509671 B1 EP 3509671B1
Authority
EP
European Patent Office
Prior art keywords
dose
ratchet
injection device
splines
spring
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP17764597.5A
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German (de)
English (en)
Other versions
EP3509671A1 (fr
Inventor
Karl James Hewson
Jeremy James Robert KOOYMAN
Xorge CASTRO PELAYO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Norton Healthcare Ltd
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Norton Healthcare Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31553—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126—Specific display means related to dosing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir

Definitions

  • This disclosure relates to the field of a dose setting mechanism for an injection device, preferably a reusable pen-type injection device.
  • Certain injection devices have a dose setting member, or dose selector, via which the user can select a desired dose of medicament to be delivered from the injection device.
  • the dose selector can commonly be actuated in one direction to increase the set dose ("dialling up”) and actuated in another direction to decrease the set dose (“dialling down”). As the dose is dialled up or down, this correspondingly increases or decreases stored energy in the device (e.g. in a torsion spring).
  • An example of this type of dose setting can be seen in WO2006/045528 .
  • a drive member is connected to a dose setting member via a self-tightening ratchet having saw-toothed teeth.
  • the ratchet enables the dose setting member to be rotated in both directions so that a given dose may be set, whilst preventing the spring from unwinding from the currently selected dose.
  • Such dose setting ratchets have the additional advantage of creating audible and tactile feedback for each dose unit dialled by the user.
  • WO2015/007820 A relates to a drug delivery device for selecting and dispensing a number of user variable doses of a medicament.
  • US2011/077595 A1 relates to a brake mechanism for an injection device for generating a braking action on a moving, e.g. rotating, part or component of the injection device.
  • WO2013/178372 A1 relates to a torsion spring driven injection device having a dial-down mechanism for dialling down a selected dose size.
  • an injection device comprising:
  • the assembly of three components provides greater reliability during dose selection.
  • the splines for disengaging the ratchet improve the smoothness of operation during decrementing of the dose.
  • Having a single ratchet component serves two functions, interacting with both the dose selector and the drive plate, which makes the dose setting more reliable.
  • the dose selector is operatively connectable to the dose indicator via said ratchet arrangement, the ratchet arrangement preventing counter-rotation of the dose indicator during dose setting.
  • the ratchet arrangement is disengagable from the dose selector by axial depression of the dose button.
  • the injection device further comprises an over-torque feature located between the dose selector and the spring, the over-torque feature being actuatable, when the rotation of the dose selector causes the charging force to exceed a defined limit, to reduce the charging force transferred from the dose selector to the spring.
  • the over-torque feature is capable of reducing the charging force transferred from the dose selector to the spring to substantially zero.
  • the over-torque feature may comprise a ratchet arrangement between said drive plate and said dose selector.
  • the ratchet arrangement comprises a ratchet pawl on said dose selector and a second set of splines on said drive plate.
  • the spring is a torsion spring and the charging force transferred to the spring is a charging torque.
  • the injection device further comprises a drive assembly having a rotational to axial coupling, where the drive assembly is rotationally drivable by the spring and is arranged to provide an axial force for ejecting the dose from the injection device.
  • the spring is fixed at one end to said housing and fixed at the other end to a rotatable drive sleeve.
  • the drive plate may further comprise a third set of splines for engaging and turning said drive sleeve.
  • the drive plate may further comprise a fourth set of splines for engaging said drive assembly.
  • the dose indicator comprises a number sleeve.
  • the ratchet ring may include a rotary endstop for said number sleeve.
  • said ratchet component comprises a first pawl capable of interacting with the splines on the dose selector and a second pawl capable of interacting with the splines on the drive plate.
  • Said first pawl and second pawl may be provided on a single ratchet arm which is preferably radially-moveable.
  • the injection device further comprises a medicament container.
  • the medicament container comprises a pre-filled syringe or cartridge.
  • medicament is contained in the medicament container, wherein the medicament may be selected from the group comprising: antipsychotic substances including risperidone, hormones, antitoxins, substances for the control of pain, immunosuppressives, substances for the control of thrombosis, substances for the control or elimination of infection, peptides, proteins, human insulin or a human insulin analogue or derivative, polysaccharide, DNA, RNA, enzymes, antibodies, oligonucleotide, antiallergics, antihistamines, anti-inflammatories, corticosteroids, disease modifying anti-rheumatic drugs, erythropoietin, or vaccines, for use in the treatment or prevention of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hormone deficiency, toxicity, pain
  • antipsychotic substances including
  • injection device may refer to a device intended for the injection of a medicament to the body and includes devices configured for various delivery methods, such as intradermal, subcutaneous, intramuscular, intravenous, intraosseous, intraperitoneal, intrathecal, epidural, intracardiac, intraarticular, intracavernous, and intravitreal, which may include via a cannula, catheter or similar device.
  • Injection device includes syringes of all types, devices that contain said syringes such as auto-injectors, pen-injectors, patch injectors and other similar devices.
  • pen-injector may include any device configured to deliver a dose of a medicament from a cartridge.
  • the term "user” may refer to a medical practitioner, end user or other user associated therewith.
  • Coupled may refer to a connection between components (not necessarily a direct connection; there may be intermediate components therebetween) that enables a force to be transmitted between the components.
  • a rotational coupling may refer to a coupling which enables a rotational force to be transmitted between the components.
  • operatively connectable may refer to at least two individual components which are releasably connectable together in such a way that the individual components can work together, for example wherein rotation of one of the individual components effects rotation of all of the operatively connected components.
  • dose selector may refer to a component or components which, when actuated by a user, enable a dose of medicament to be selected.
  • dose indicator may refer to a component or components which provide a display or indication to the user of the selected dose of medicament.
  • splines may refer to one or more ridges, ribs or other protrusions on one component which engage in corresponding grooves or the like on a second component to connect the two components together.
  • a splined connection may refer to a connection effected by one or more splines.
  • forward may refer to a direction towards the end of the injection device from which medicament is expelled;
  • backward may refer to a direction away from the end of the injection device from which medicament is expelled.
  • driver assembly may refer to an assembly of components capable of using a driving force from, for example, a spring, to eject medicament from an injection device.
  • lash may refer to a clearance caused by a gap between mechanical components.
  • the term “medicament” may include a substance in liquid or gas form.
  • the medicament may be selected from the group comprising of: antipsychotic substances including risperidone, hormones, antitoxins, substances for the control of pain, immunosuppressives, substances for the control of thrombosis, substances for the control or elimination of infection, peptides, proteins, human insulin or a human insulin analogue or derivative, polysaccharide, DNA, RNA, enzymes, antibodies, oligonucleotide, antiallergics, antihistamines, anti-inflammatories, corticosteroids, disease modifying anti-rheumatic drugs, erythropoietin, or vaccines, for use in the treatment or prevention of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hormone deficiency, toxicity, pain, thrombosis, infection, diabetes mellitus, diabetic retinopathy, acute coronary syndrome,
  • the term "containing the medicament” may refer to the medicament being contained within a suitable medicament container, such as a pre-filled syringe or cartridge, within the injection device.
  • ratchet arrangement may refer to an arrangement of components comprising a set of splines or teeth and a “ratchet component” which can engage in said splines or teeth to permit one-way movement.
  • over-torque feature may refer to a feature located on a first component and capable of interacting with a second component so as to reduce a force being transferred along a force path from the first component to the second component, for example by changing the direction of the force path and/or creating an additional force path.
  • single component may refer to one component, an integrally-formed component, a unitary component, or at least two component parts fixed together or with respect to one another.
  • haptic feedback track may refer to a plurality of ridges, ribs, teeth, or other protrusions on an internal surface of the injection device and with which another component, moving rotationally with respect thereto, can engage to provide audible and/or tactile feedback to a user of the injection device.
  • a dose button may refer to a button or the like at the rear of the injection device which is actuated, for example by pressing axially-forwardly with respect to the device housing, in order to initiate dose delivery.
  • FIG. 1-3 An injection device 400 according to a non-limiting example embodiment of the present invention is shown in Figures 1-3 .
  • the injection device 400 is configured to deliver a dose of medicament and extends along a longitudinal axis L between a front end 400a and a rear end 400b of the injection device 400.
  • the injection device 400 has a housing 412 and is able to receive a needle (not shown) at the front end 400a.
  • a dose selector 416 is provided at the rear end 400b and is arranged to permit the selection of a desired dose of medicament for delivery through the needle into an injection site.
  • the housing 412 includes an aperture 412a through which a dose indicator, for example a number sleeve 418 is visible.
  • a cartridge holder 425 holds a medicament cartridge 424 from which medicament is expelled by the forward axial movement of a cartridge stopper 426.
  • the cartridge stopper 426 is driven axially forward by a drive mechanism described later below.
  • the components of the injection device are arranged generally concentrically about longitudinal axis L. Beginning at the rear end 400b of the injection device 400, a dose button 430 is biased axially rearward by a dose button spring 431. Three interacting components, the dose selector 416, a ratchet ring 410 and a drive plate 405 are involved in a dose setting mechanism which sets the desired dose to be delivered.
  • a drive spring 420 is attached at one end to a chassis 443 which is fixed with respect to the housing 412. The other end of the drive spring 420 is fixed to a drive sleeve 439.
  • a last dose nut 441 is threaded to an elongate drive shaft 440.
  • An external surface of the last dose nut 441 has three equally spaced grooves 441a in which internal splines 439b on the drive sleeve engage.
  • the last dose nut 441 also has an endstop 441b for engaging with a correspondingly-shaped endstop 440a on the drive shaft 440.
  • the drive shaft 440 is rotationally locked to the chassis 443 by a chassis ratchet 442.
  • the chassis ratchet 442 is a one-way ratchet which locks the drive shaft 440 to the chassis 443 in a clockwise (dose setting) direction, whilst allowing relative rotation of the drive shaft 440 with the chassis 443 in an anti-clockwise (dose delivery) direction.
  • a rear end of the drive shaft 440 is provided with a set of internal splines 440b ( Figure 38B ) which can engage with the drive plate 405.
  • a front end of the drive shaft 440 is provided with a set of external splines 440c ( Figure 42 ) for keying i.e. rotationally locking the drive shaft 440 to a hollow plunger 444.
  • the hollow plunger 444 is capable of converting rotation of the drive shaft 440 into linear (axial) motion via a thrust nut 445 (an external screw thread of the plunger 444 being engaged with the thrust nut 445).
  • a plunger bearing 446 at the forward end of the plunger 444 can be pushed axially against the cartridge stopper 426 to expel medicament.
  • the dose selector 416 shown in Figures 4A and 4B includes a set of axially-extending splines 416a viewable from the front of the dose selector 416. These splines are involved in the disengagement of a hold ratchet arrangement. Viewable from the rear of the dose selector 416 are two ratchet pawls 416b, spaced 180 degrees apart. The ratchet pawls 416b are part of an over-torque feature. An external surface of the dose selector 416 is provided with a pattern of grip formations 416c to increase friction and to visually indicate to a user where to grip the injection device 400 in order to set the dose.
  • FIGS 5A and 5B show the drive plate 405.
  • the drive plate 405 includes a flange 405a for connecting the drive plate 405 to the dose button 430.
  • Arranged axially along the drive plate 405 are four sets of splines.
  • a first set of splines 406 forms part of the hold ratchet arrangement.
  • Located axially rearwardly of the first set of splines 406 (i.e. towards the rear end 400b of the injection device 400) is a second set of splines 407.
  • the second set of splines 407 has a smaller maximum diameter than the first set of splines 406.
  • a third set of three widely and equally-spaced splines 408 which are capable of engaging the drive sleeve 439.
  • a fourth set of splines 409 which are capable of engaging the drive shaft 440.
  • FIGs 6A - 6C show the ratchet ring 410.
  • the ratchet ring 410 includes two notches 410a which engage corresponding formations on the housing 412 to lock the ratchet ring 410 axially and rotationally with respect to the housing 412 ( Figure 7 ).
  • the ratchet ring 410 could be formed as an integral part of the housing 412.
  • the ratchet ring 410 is held or arranged between or adjacent to the housing 412 and the dose selector 416.
  • the ratchet ring 410 includes a hard rotary endstop 410e for the number sleeve 418.
  • the ratchet ring 410 includes a flexible ratchet arm 410b, at the end of which is a ratchet component in the form of two adjacent ratchet pawls 410c, 410d.
  • the ratchet pawls 410c, 410d have different depths and/or angled surfaces so that, when the dose setting mechanism is assembled together, the ratchet pawl 410c is able to engage the first set of splines 406 on the drive plate 405 and the ratchet pawl 410d is able to engage the splines 416a on the dose selector 416.
  • the drive sleeve 439 has three equally spaced longitudinally extending external splines 439a which engage in longitudinal grooves 418a on an internal surface of the number sleeve 418.
  • the number sleeve 418 can therefore move axially with respect to the drive sleeve 439 but is rotationally locked thereto.
  • An external surface of the number sleeve 418 has a helical groove 418b which engages with a thread 412b on an internal surface of the housing 412. The number sleeve 418 can therefore rotate with respect to the housing 412, guided by the thread 412b.
  • Figures 12A and 12B show an exploded view and an assembled view of the dose selector, ratchet ring and drive plate, viewed from the rear of the injection device.
  • Figures 13A and 13B are an exploded view and an assembled view of the dose selector, ratchet ring and drive plate, viewed from the front of the injection device.
  • the user turns the dose selector 416 clockwise.
  • the dose selector ratchet pawl 416b starts to engage and drive the drive plate 405 clockwise via the second set of splines 407 on the drive plate 405 ( Fig 14B ).
  • the ratchet ring 410 is rotationally fixed or being integral to the housing 412 and does not rotate.
  • the ratchet ring first pawl 410c is engaged with the drive plate splines 406 in order to provide a hold ratchet arrangement.
  • the dose selector splines 416a start to engage the second pawl 410d of the ratchet ring 410.
  • a first rotation of 1 to 3 degrees, in the embodiment 1.7° of rotation does not move the pawl 410d, or the ratchet arm 410b to which it is attached ( Fig 16B ).
  • the dose selector 416 When the dose selector 416 has been rotated 5 to 12 degrees, preferably between 7 to 10 degrees, in the embodiment 8.6° ( Fig 16C ), the dose selector splines 416a have pushed the pawl 410d and ratchet arm 410b radially outwardly by 0.1 mm to 1 mm, in the embodiment 0.25mm so that the pawl 410d disengages from the dose selector splines 416a. The hold ratchet is still engaged, however, because the first ratchet ring pawl 410c is still engaged with the drive plate splines 406.
  • the dose selector 416 has been rotated 10 to 20 degrees, preferably between 13 to 17 degrees, in the embodiment 14.6° (( Fig 16D ) the drive plate splines 406 push the first pawl 410c, causing the ratchet arm 410b to move radially outwardly to 0.3 mm to 1.5 mm, in the embodiment 0.41mm.
  • the hold ratchet temporarily disengages as the first pawl 410c disengages from the drive plate splines 406.
  • the ratchet arm 410b clicks over into the next splines i.e. the first pawl 410c engages the next drive plate spline 406 and the second pawl 410d engages the next dose selector spline 416a. This produces haptic feedback for the user and re-engages the hold ratchet ( Fig 16E ), whereupon the process can be repeated if the dose is to be incremented further.
  • the drive plate 405 rotates the drive sleeve 439 by virtue of the third set of drive plate splines 408 ( Figure 20 ).
  • the drive sleeve 439 is locked to the drive spring 420, winding (and therefore charging) the spring 420 as the drive sleeve 439 turns ( Figure 21 ).
  • the drive spring 420 is fixed at its other end to the chassis 443 ( Figure 22 ).
  • the drive sleeve 439 turns, it turns the number sleeve 418 by virtue of the external drive sleeve splines 439a ( Figure 10 ). As the number sleeve 418 turns, it advances along the thread 412b on the internal surface of the housing 412 ( Figure 11 ). The number sleeve 418 cannot advance further than a hard endstop 412c on an internal surface of the housing 412 which prevents further rotation of the number sleeve 418 ( Figure 23B ).
  • the user turns the dose selector 416 anti-clockwise ( Figure 24A ).
  • the dose selector 416 As the dose selector 416 is turned anti-clockwise, there is a small amount of lost motion such that the dose selector 416 rotates slightly, preferably between 1 to 8 degrees relative to the ratchet pawl 416b.
  • the hold ratchet will disengage and the dose selector ratchet pawl 416b can start to drive the drive plate 405 anti-clockwise via the second set of splines 407 on the drive plate 405 ( Figure 24C ).
  • the ratchet ring 410 is rotationally fixed to the housing 412 and does not rotate.
  • the ratchet ring first pawl 410c is engaged with the drive plate splines 406 and the ratchet ring second pawl 410d is engaged with the dose selector splines 416a so as to provide the hold ratchet arrangement ( Figure 26A ).
  • the splines 406, 416a are pushing against the pawls 410c, 410d as a result of the stored energy in the drive spring 420.
  • the dose selector 416 As the dose selector 416 is turned anti-clockwise, the first 1 to 5 degrees, in the embodiment 3.7° of rotation pushes the ratchet arm 410b 0.1 mm to 0.5 mm in the specific embodiment 0.14mm radially outwardly ( Figure 26B ).
  • the drive plate 405 After 3 to 6 degrees, in the embodiment 3.7° of rotation, the drive plate 405 starts to turn with the dose selector 416, further disengaging the hold ratchet and allowing the drive plate 405 to turn ( Figure 26C ).
  • the hold ratchet then re-engages; the pawls 410c, 410d catching on the next splines 406, 416a and providing haptic feedback ( Figure 26D ).
  • the dose decrementing process is summarised in Figure 28 , in which it can be seen that the dose selector 416 turns the drive plate 405.
  • the drive plate 405 turns the drive sleeve 439.
  • the drive sleeve 439 turns the drive spring 420 to discharge it and also turns the last dose nut 441 and the number sleeve 418.
  • the number sleeve 418 will progress backwards, decrementing the indicated dose, until it reaches the hard rotary endstop 410e on the ratchet ring 410 ( Figure 29B ).
  • over-torque feature is illustrated in Figures 30A and 30B .
  • the over-torque feature is in the form of a ratchet arrangement is provided by the dose selector ratchet pawls 416b and the second set of splines 407 on the drive plate 405. If the number sleeve 418 has reached the endstop 410e or if the last dose protection (see below) is engaged, the over-torque feature protects components from potential damage caused by continued turning of the dose selector 416 by the user.
  • the ratchet pawls 416b are displaced radially outwardly by 0.35mm to disengage them from the splines 407, clicking over them to reduce the charging force transferred from the dose selector 416 to the drive spring 420.
  • the over-torque for actuating the over-torque protection is preferably at least 10% higher than the torque required for dialling up (incrementing) or dialling down (decrementing) the dose selector 416.
  • the dialling up torque can be 30 to 80 Nmm, preferably less than 60 Nmm, more preferably 30 to 50 Nmm.
  • the dialling down torque can be 20 to 60 Nmm, preferably less than 50 Nmm, more preferably 30 to 40 Nmm.
  • the over-torque in the dialling up direction may be different to the over-torque in dialling down direction.
  • Last dose protection is provided by the last dose nut 441, as illustrated in Figures 31 - 33 .
  • the drive sleeve 439 turns, it turns the last dose nut 441 which is splined thereto. This causes the last dose nut 441 to travel axially rearwardly along the drive shaft 440 to which it is threaded.
  • the drive shaft 440 itself does not rotate during dose setting because it is rotationally locked to the chassis 443 via the chassis ratchet 442.
  • the last dose nut 441 moves axially 0.5 mm to 1mm, preferably about 0.7mm each turn. After 13.166 turns (representing 316IU of medicament) the last dose nut 441 has moved sufficiently so that its endstop 441b has reached the hard rotary endstop 440a on the drive shaft 440. The last dose protection is now engaged and further incrementing of the dose is no longer possible.
  • Figure 34 shows the rear of the injection device 400 ready to deliver a dose of medicament.
  • the dose button 430 is biased rearwardly by the dose button spring 431 and has not yet been pressed.
  • the hold ratchet is engaged, i.e. the ratchet ring first pawl 410c is engaged with the first set of splines 406 on the drive plate 405.
  • the over-torque feature is also engaged, i.e. the dose selector ratchet pawls 416b are engaged with the second set of splines 407 on the drive plate 405.
  • the drive plate 405 is moved axially forward by the dose button 430 which is engaged with the rear of the drive plate 405.
  • the forward axial movement of the drive plate 405 means that the dose selector ratchet pawls 416b (which have not moved axially) are no longer engaged with the splines 407, thus the over-torque feature is disengaged and the drive plate 405 is free of the dose selector 416 ( Figure 35B ).
  • Figure 38A shows the dose button 430 fully depressed, its axial travel limited by abutting the dose selector 416.
  • the drive plate 405 and drive shaft 440 are fully engaged and able to rotate freely, driven by the drive spring 420 to deliver the desired dose of medicament.
  • the one-way chassis ratchet 442 allows the drive shaft 440 to rotate with respect to the chassis 443, during which haptic feedback is provided to the user by the clicking of the chassis ratchet 442.
  • Figure 39 shows how the fourth set of splines 409 on the drive plate 405 engage with the internal splines 440b of the drive shaft 440.
  • the one-way chassis ratchet 442 is also visible at the rear of the chassis 443.
  • the relative rotational positions of the drive plate 405 and drive shaft 440 is important, to ensure the splines 409, 440b mesh smoothly ( Figure 38b ).
  • the splines 409, 440b are designed to allow up to 1 to 2 degrees of rotational displacement or play between splines 409, 440b.
  • Figure 40 shows typical relative positions of the hold ratchet pawl 410c and drive plate splines 406 (leftmost Figure), the chassis ratchet 442 and drive shaft 440 (centre Figure) and the drive plate splines 409 and internal drive shaft splines 440b (rightmost Figure). A 0.81° overlap does not prevent the drive plate 405 and drive shaft 440 from engaging smoothly.
  • Figure 41 shows the most extreme possible relative positions of the hold ratchet pawl 410c and drive plate splines 406 (leftmost Figure), the chassis ratchet 442 and drive shaft 440 (centre Figure) and the drive plate splines 409 and internal drive shaft splines 440b (rightmost Figure).
  • a 1.81° overlap still allows the drive plate 405 and drive shaft 440 to engage smoothly.
  • Dose delivery can be summarised with reference to Figure 42 .
  • the charged drive spring 420 is fixed at one end to the drive sleeve 439, turning it anti-clockwise.
  • the drive sleeve 439 turns the number sleeve 418 which is splined thereto, causing the number sleeve 418 to move axially backwards because it is engaged with the screw thread 412b in the housing 412 (not shown).
  • the drive sleeve 439 turns the drive plate 405 because of splines 408.
  • the drive plate 405 is engaged with the drive shaft 440 via splines 409 (not visible) and so the drive shaft 440 also turns.
  • the last dose nut 441 turns with the drive sleeve 439 and drive shaft 440 but does not move axially with respect thereto.
  • the drive shaft 440 turns, it turns the hollow plunger 444 which is rotationally locked, or keyed, thereto.
  • the thrust nut 445 causes the screw-threaded hollow plunger 444 to advance axially forwards, pushing the plunger bearing 446 against the cartridge stopper 426 (not shown) into the cartridge 424 (not shown) to expel the dose of medicament.
  • Figure 43 summarises schematically the mechanical motion transfer of the injection device components.
  • Figure 44 is a diagrammatic summary of the key engagement points of the components of the injection device, at five stages of dose delivery.
  • the injection device 400 comprises:

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (13)

  1. Dispositif d'injection (400) comprenant :
    a. un boîtier (412) présentant un axe longitudinal ;
    b. un bouton de dose à pression axiale (430) ;
    c. un indicateur de dose (418) ;
    d. un mécanisme de réglage de dose (405, 410, 416) couplé fonctionnellement audit indicateur de dose (418) et capable de régler une dose à éjecter du dispositif d'injection (400) ; et
    e. un ressort (420) capable de stocker l'énergie nécessaire pour éjecter la dose du dispositif d'injection (400), dans lequel le ressort est couplé au mécanisme de réglage de dose de telle sorte qu'une force de charge puisse être transférée du mécanisme de réglage de dose au ressort pour augmenter l'énergie stockée par le ressort (420) ;
    caractérisé en ce que le mécanisme de réglage de dose comprend un ensemble de trois composants, comprenant :
    une bague à rochet (410) verrouillée en rotation et axialement par rapport audit boîtier (412), la bague à rochet comprenant un composant de rochet (410b, 410c, 410d) ;
    une plaque d'entraînement (405) comprenant un premier ensemble de cannelures (406) et un second ensemble de cannelures (407) ; et
    un sélecteur de dose (416) capable de tourner autour dudit axe longitudinal par rapport audit boîtier (412) pour incrémenter et décrémenter la dose et comprenant des cannelures (416a) et un cliquet à rochet (416b),
    dans lequel ledit composant à rochet (410b, 410c, 410d) comprend un premier cliquet (410c) capable d'interagir avec les cannelures (406) sur la plaque d'entraînement (405) et un second cliquet (410d) capable d'interagir avec les cannelures (416a) sur le sélecteur de dose (416), et
    dans lequel un agencement de rochet est formé entre ledit composant de rochet (410b, 410c, 410d) et ledit premier ensemble de cannelures (406) et est formé entre ledit cliquet à rochet (416b) et ledit deuxième ensemble de cannelures (407).
  2. Dispositif d'injection (400) selon la revendication 1, dans lequel le sélecteur de dose (416) peut être connecté de manière opérationnelle à l'indicateur de dose (418) via ledit agencement de rochet, l'agencement de rochet empêchant la contre-rotation de l'indicateur de dose (418) pendant le réglage de dose.
  3. Dispositif d'injection (400) selon la revendication 2, dans lequel l'agencement de rochet peut être désengagé du sélecteur de dose (416) par enfoncement axial du bouton de dose (430).
  4. Dispositif d'injection (400) selon l'une quelconque des revendications précédentes, comprenant en outre une caractéristique de sur-couple située entre le sélecteur de dose (416) et le ressort (420) comprenant un agencement de rochet entre ladite plaque d'entraînement (405) et ledit sélecteur de dose (416), la caractéristique de sur-couple pouvant être actionnée, lorsque la rotation du sélecteur de dose (416) amène la force de charge à dépasser une limite définie, pour réduire la force de charge transférée du sélecteur de dose (416) au ressort (420).
  5. Dispositif d'injection (400) selon la revendication 4, dans lequel la caractéristique de sur-couple est capable de réduire la force de charge transférée du sélecteur de dose (416) au ressort (420) à sensiblement zéro.
  6. Dispositif d'injection (400) selon l'une quelconque des revendications précédentes, dans lequel le ressort (420) est un ressort de torsion et la force de charge transférée au ressort est un couple de charge.
  7. Dispositif d'injection (400) selon l'une quelconque des revendications précédentes, comprenant en outre un ensemble d'entraînement ayant un couplage rotation-axial, où l'ensemble d'entraînement peut être entraîné en rotation par le ressort (420) et est agencé pour fournir une force axiale pour éjecter la dose depuis le dispositif d'injection (400).
  8. Dispositif d'injection (400) selon l'une quelconque des revendications précédentes, dans lequel le ressort (420) est fixé au niveau d'une extrémité audit boîtier (412) et fixé au niveau de l'autre extrémité à un manchon d'entraînement rotatif (439).
  9. Dispositif d'injection (400) selon la revendication 8, dans lequel la plaque d'entraînement (405) comprend en outre un troisième ensemble de cannelures (408) pour engager et tourner ledit manchon d'entraînement (439).
  10. Dispositif d'injection (400) selon la revendication 7, dans lequel la plaque d'entraînement (405) comprend en outre un quatrième ensemble de cannelures (409) pour engager ledit ensemble d'entraînement.
  11. Dispositif d'injection (400) selon l'une quelconque des revendications précédentes, dans lequel l'indicateur de dose (418) comprend un manchon numéroté (418) et, de préférence, dans lequel ladite bague à rochet (410) comprend une butée rotative (410e) pour ledit manchon numéroté (418).
  12. Dispositif d'injection (400) selon l'une quelconque des revendications précédentes, dans lequel ledit premier cliquet (410c) et ledit second cliquet (410d) sont prévus sur un même bras à rochet (410b) et, de préférence, dans lequel ledit bras à rochet (410b) est mobile radialement.
  13. Dispositif d'injection (400) selon l'une quelconque des revendications précédentes, comprenant en outre un contenant de médicament, de préférence une seringue ou cartouche pré-remplie, comprenant en outre de préférence un médicament contenu dans le contenant de médicament, dans lequel le médicament est choisi dans le groupe comprenant : les substances antipsychotiques comprenant la rispéridone, les hormones, les antitoxines, les substances pour le contrôle de la douleur, les immunosuppresseurs, les substances pour le contrôle de la thrombose, les substances pour le contrôle ou l'élimination d'infection, les peptides, les protéines, l'insuline humaine ou un analogue ou dérivé de l'insuline humaine, un polysaccharide, l'ADN, l'ARN, les enzymes, les anticorps, les oligonucléotides, les antiallergiques, les antihistaminiques, les antiinflammatoires, les corticostéroïdes, les médicaments antirhumatismaux modifiant l'évolution de la maladie, l'érythropoïétine ou les vaccins, pour utilisation dans le traitement ou la prévention de la polyarthrite rhumatoïde, de l'arthrite psoriasique, de la spondylarthrite ankylosante, de la colite ulcéreuse, du déficit hormonal, de la toxicité, de la douleur, de la thrombose, de l'infection, du diabète sucré, de la rétinopathie diabétique, du syndrome coronarien aigu, de l'angine, de l'infarctus du myocarde, de l'athérosclérose, du cancer, de la dégénérescence maculaire, de l'allergie, du rhume des foins, de l'inflammation, de l'anémie ou de la myélodysplasie, ou dans l'expression de l'immunité protectrice.
EP17764597.5A 2016-09-12 2017-09-11 Mécanisme de réglage de dose Active EP3509671B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1615442.9A GB201615442D0 (en) 2016-09-12 2016-09-12 Dose setting mechanism
PCT/EP2017/072714 WO2018046717A1 (fr) 2016-09-12 2017-09-11 Mécanisme de réglage de dose

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EP3509671A1 EP3509671A1 (fr) 2019-07-17
EP3509671B1 true EP3509671B1 (fr) 2020-12-09

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WO2017158033A1 (fr) * 2016-03-15 2017-09-21 Sanofi Mécanisme de dosage pour dispositif d'injection multi-injection comprenant un élément cliquet souple
USD827127S1 (en) * 2016-12-14 2018-08-28 Teva Pharmaceutical Industries Ltd. Injector pen
JP1631348S (fr) * 2017-11-06 2019-05-13
JP7289297B2 (ja) * 2017-12-04 2023-06-09 ノボ・ノルデイスク・エー／エス 撓み可能な変換器を有する薬剤注入デバイス
RU2696459C1 (ru) * 2019-02-21 2019-08-01 Общество с ограниченной ответственностью «НЭКСТ БИО» Инъекционное устройство
CN110141727B (zh) * 2019-05-06 2024-07-30 甘甘医疗科技江苏有限公司 药物输送装置
RU2729432C1 (ru) * 2019-10-23 2020-08-06 Общество с ограниченной ответственностью «НЭКСТ БИО» Устройство для доставки лекарственного средства
CN110681004A (zh) * 2019-11-15 2020-01-14 苏州嘉树医疗科技有限公司 一种自动注射器
PL241093B1 (pl) * 2020-06-17 2022-08-01 Copernicus Spolka Z Ograniczona Odpowiedzialnoscia Mechanizm sterujący wstrzykiwacza do podawania dawki leku i odpowiedni wstrzykiwacz do podawania dawki leku
US20240058544A1 (en) * 2021-04-16 2024-02-22 Shandong Wego Prefills Pharmaceutical Packaging Co., Ltd Multi-dose adjustable pre-charge injection pen

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Publication number Publication date
GB201615442D0 (en) 2016-10-26
US20190366009A1 (en) 2019-12-05
US11338093B2 (en) 2022-05-24
WO2018046717A1 (fr) 2018-03-15
EP3509671A1 (fr) 2019-07-17

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